Wednesday, August 26, 2015

The emminently capable Magistrate Judge Pohorelsky, sitting in Brooklyn's federal District courthouse has ruled that the doctor will be given one additionnal week to prepare, but that both she -- and her Weill-Cornell Medical Center lawyer -- WILL in fact have to appear personally, to answer his questions about the state of the play, on these supposed 16 to 40 boxes of study documents. Now that is. . . fascinating.

So -- if anyone were to wander by (and bring a picture ID, to be granted admission to the gallery) they could sit in that day, in Brooklyn. It could turn out to be a pretty darn interesting show cause hearing, given the interplay between what has been reported to be the doctor's earlier position -- per her lawyer -- and what we all understand the federal rules governing national clinical trials for FDA approval of new drug candidates might have required of her. Do stay tuned, but I have no plans to be in New York that day, at this point. Here is the full text of today's order -- just entered, below:

. . . .Order on Motion for Discovery: the Hearing on the Order to Show Cause is adjourned to September 10, 2015 at 12:00 noon. Dr. Julianne Imperato-McGinley and her counsel are both required to attend in person. Ordered by Magistrate Judge Viktor V. Pohorelsky on 8/25/2015. . . .

The delay from September 2 -- to September 10 -- was designed to accommodate the doctor's availabilty -- to appear in person. Pop the popcorn folks! [And, in answer to Mr. E (below), there was no status hearing scheduled for today, given yesterdaty's developments -- it was superceded/deleted.] Onward.

I know we've touched on this before but I thought of a question as well.... how involved do you think Merck has been in this whole thing? Meaning, from the point Dr. I-M was served a subpoena all the way up until this show cause hearing. This is a very significant point in the MDL so I would have to think they are involved or are advising Dr. I-M in some capacity.

Yeah, and that relates to what I was touching on in a previous post. Merck is allegedly the real defendant here, so Cornell presumably has little or nothing to lose...so what's up with the (potential) stonewalling? - Mr. I

Hey guys -- (as I've said) I think the doctor is fairly isolated in academia, and has very little real concern for how the finasteride debate has evolved in the public sphere over the years. She thinks it beneath her, in all likelyhood.

She likely agrees with Merck's position -- that if we all better understood the science involved -- we'd feel that the plaintiffs' claims have no basis, in scientific fact. [I remain open to either possibility, for the record -- and I do think the documents from the old clinical trials will help us, to a small degree, start to sort that question out.]

So -- I doubt Merck is encouraging her (or Weill-Cornell) to do, or not do, much of anything.

I think she likely thinks she owes no big duty here -- to anyone -- and is possibly a little annoyed that she's had to waste time searching for records. But if that's the face she shows to the Magistrate Judge -- watch out.

Me? I'll go back to betting that the document delivery immediately prior to September 10, 2015 will be pretty hefty -- at least 10 to 15 boxes worth -- simply to avoid the whiff that something is being "hidden". For its part, Merck would like to hold a "science day" for the court, to make clear what its beliefs are about the underlying chemistry and science -- of human biology.

"I think she likely thinks she owes no big duty here -- to anyone -- and is possibly a little annoyed that she's had to waste time searching for records. But if that's the face she shows to the Magistrate Judge -- watch out."

This part I find a bit confusing though. I can understand that the doctor may think the plaintiffs don't have a case, and I can understand her finding this all to be a waste of time. But even if she privately were to feel that way, I would think being ordered by a court would register as a big deal which ought to have made stonewalling seem less of an option.

Here's yet another question from me, the uninitiated: assuming the boxes get turned over, will the public have any chance to learn anything about the findings, or will that just be in the hands of the plaintiffs lawyers up until the belwether trials? - Mr. I

Regarding the stonewalling, that's what I was getting at before. I understand that stalling and delaying are common tactics in these types of situations but it seems to me that Dr. I-M and Weill-Cornell have taken some extreme measures... ignoring the subpoena and claiming she never was served, saying the documents were not in her possession (which is impossible), asking for more time as there were up to 40 boxes, and then only turning over a half of a box. I cannot imagine any judge being amused by these events.

More FDA Resources. . .

Blog Archive

Senator Grassley's Concern

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FDA Drug Facts

The Condor. . . .

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